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Deciphera(DCPH) - 2023 Q2 - Earnings Call Transcript
2023-08-09 17:28
Financial Data and Key Metrics Changes - Total revenue for Q2 2023 was $38.3 million, an 18% increase compared to $32.5 million in Q2 2022, with net product revenue from QINLOCK at $37.3 million [45][46] - QINLOCK generated over $38 million in revenue for Q2, marking an 18% increase year-over-year [4] - Research and development expenses rose to $58.3 million from $44.9 million in the same period last year [47] - Cash, cash equivalents, and marketable securities stood at $389.4 million as of June 30, 2023 [48] Business Line Data and Key Metrics Changes - U.S. net product revenue for QINLOCK was $28.9 million in Q2, representing a 17% increase from Q1 and a 22% increase year-over-year [32] - International revenue for QINLOCK was $8.4 million, up from $7.8 million in the prior year, driven by volume growth despite a lower monthly price in Germany [36] Market Data and Key Metrics Changes - The U.S. market saw continued momentum in demand drivers, including new prescriber growth and patient acquisition, with over 1,000 QINLOCK prescribers to date [10][11] - In Europe, QINLOCK is well-received due to high unmet medical needs, particularly in Germany, with ongoing efforts to launch in Italy and Singapore [14][38] Company Strategy and Development Direction - The company aims to expand the QINLOCK label to include second-line GIST patients with specific KIT mutations, with the INSIGHT study serving as a basis for a Supplemental New Drug Application [26][27] - The company is focused on advancing its pipeline, including the upcoming topline results from the Phase 3 MOTION study and IND submissions for new drug candidates [29][73] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the commercial momentum and the potential for QINLOCK to become the standard-of-care in fourth-line GIST [12][35] - The company anticipates continued growth in demand and is preparing for the topline readout of the MOTION study in Q4 2023, which could lead to the approval of vimseltinib [50][146] Other Important Information - The company announced the retirement of Dan Flynn, the Founder and Chief Scientific Officer, and welcomed Dr. Dash Dhanak as the new Chief Scientific Officer [8][30] - The company is optimistic about the potential of DCC-3116 as a first-in-class combination agent across various cancers [68] Q&A Session Summary Question: What is the timeline for filing after the MOTION trial readout? - Management indicated that they would provide an update on potential filing timelines after the topline report in Q4 [80] Question: What are the expectations for the Phase 1/2 update? - The update will include longer follow-up data, safety information, and patient-reported outcomes [81] Question: What is the enrollment timeline for the INSIGHT trial? - Management noted that they are optimistic about enrollment and will provide updates as more sites open [111] Question: What are the collaboration revenue expectations for the second half of the year? - Collaboration revenue is expected to increase over time, primarily from royalty revenues [113] Question: What are the implications of dose-limiting toxicities observed in DCC-3116 combinations? - Management clarified that the observed toxicities may be related to the standard-of-care drugs used in combination rather than DCC-3116 itself [92][118] Question: How is the company addressing the competitive landscape for vimseltinib? - Management is actively evaluating additional indications for vimseltinib and plans to disclose future opportunities [96]
Deciphera(DCPH) - 2023 Q2 - Quarterly Report
2023-08-09 11:09
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2023 OR ___________________________________________ DECIPHERA PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) ___________________________________________ ...
Deciphera(DCPH) - 2023 Q1 - Earnings Call Transcript
2023-05-07 08:58
Tucker Kelly Matt? Matt Sherman - Chief Medical Officer Thank you, operator. Welcome, and thank you for joining us today to discuss Deciphera's first quarter 2023 financial results. I'm Jen Larson, Senior Vice President of Finance and Investor Relations. Together, QINLOCK and vimseltinib have the potential to benefit thousands of patients around the world, with a peak worldwide sales potential of over $1 billion. We look forward to reporting the MOTION study results and initiating the INSIGHT study later th ...
Deciphera(DCPH) - 2023 Q1 - Quarterly Report
2023-05-03 11:10
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38219 _______________ ...
Deciphera Pharmaceuticals, Inc.(DCPH) Investor Presentation - Slideshow
2023-03-29 15:49
RTK-, RAS-, and RAF-mutant cancer cells activate autophagy in order to survive stresses or damage due to anti-cancer therapeutic intervention with MAPK and PI3K pathway inhibitors DCC-3116 | POTENTIAL BACKBONE OF COMBINATION THERAPY CENTRAL ROLE FOR AUTOPHAGY IN THE RAS/MAPK AND PI3K PATHWAYS DCC-3116 In Combination with RTK Inhibition DCC-3116 exhibits synergy with osimertinib and afatinib resulting in tumor regression in EGFR-mutant NSCLC in vivo DCC-3116 In Combination with MEK Inhibition DCC-3116 exhibi ...
Deciphera(DCPH) - 2022 Q4 - Annual Report
2023-02-07 12:17
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ______________________________________________ ______________________________________________ FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-38219 ______________ ...
Deciphera(DCPH) - 2022 Q3 - Quarterly Report
2022-11-03 11:09
Table of Contents Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 Par Value Per Share DCPH The Nasdaq Global Select Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For th ...
Deciphera(DCPH) - 2022 Q2 - Quarterly Report
2022-08-04 11:10
Table of Contents Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 Par Value Per Share DCPH The Nasdaq Global Select Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For th ...
Deciphera(DCPH) - 2022 Q1 - Quarterly Report
2022-05-04 11:12
Table of Contents Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 Par Value Per Share DCPH The Nasdaq Global Select Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For th ...
Deciphera(DCPH) - 2021 Q3 - Quarterly Report
2021-11-02 20:11
Table of Contents Securities registered pursuant to Section 12(b) of the Act: Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, $0.01 Par Value Per Share DCPH The Nasdaq Global Select Market UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 ___________________________________________ FORM 10-Q ___________________________________________ (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For th ...